TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 30, 2024 Registration No. 333-276562 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ident ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 17, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Nuwellis, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) 12988 Valley View Road Eden Prairie, Minnesota 55344 (952) 345-4200 (Add ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 NUWELLIS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Oth ...

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NUWELLIS, INC. TABLE OF CONTENTS As filed with the Securities and Exchange Commission on September 29, 2023 Registration No. 333-274610 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 (Exact name of registrant as specified in its charter) Delaware 3845 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Ide ...

As filed with the Securities and Exchange Commission on September 20, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 TABLE OF CONTENTS (Primary Standard Industrial Classification Code Number) 12988 Valley View Road Eden Prairie, Minnesota 55344 (952) 345-4200 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NUWELLIS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (A ...

FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 NUWELLIS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) 12988 Vall ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 NUWELLIS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Other Juri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended: December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission file number 001-35312 NUWELLIS, INC. (Exact name of registrant as specified in its charter) Delaware 68-0533453 (State or other jurisdiction of incorporation or o ...

Nuwellis, Inc. (NASDAQ:NUWE) Q4 2022 Earnings Conference Call February 28, 2023 8:30 AM ET Company Participants Vivian Cervantes - IR Nestor Jaramillo - President and CEO Lynn Blake - CFO Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Anthony Vendetti - Maxim Group Brooks O'Neil - Lake Street Capital Markets Operator Good morning, and welcome to the Nuwellis Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] Please note that this event is being recorded. Now ...

Financial Data and Key Metrics Changes - Revenue for Q3 2022 was $2.1 million, representing an 11% year-over-year growth but a 7% decline compared to Q2 2022. Compared to Q3 2019, revenue grew by 65% [12][39] - Gross margin increased to 61% for Q3 2022, up from 60.4% in the prior year [40] - Net loss for Q3 2022 was $3.9 million or $0.37 per share, compared to a net loss of $5.3 million or $0.75 per share in Q3 2021 [46] Business Line Data and Key Metrics Changes - Pediatric customer segment revenue grew 106% year-over-year, while critical care segment declined by 9% and heart failure segment remained flat [39][15] - Revenue mix for Q3 2022 was 42% from critical care, 37% from pediatric, and 21% from heart failure [14] Market Data and Key Metrics Changes - The company added three new accounts and reactivated five accounts in Q3 2022, selling a total of 17 consoles compared to 14 in the prior year [16] - The pediatric segment's growth reflects the company's strategic focus on this patient population, indicating a successful market penetration [13] Company Strategy and Development Direction - The company aims to make the Aquadex system the standard of care for fluid management, focusing on clinical education and a targeted sales strategy [9][36] - Key strategic initiatives include targeting outpatient clinics, expanding clinical evidence, and developing new products, particularly a pediatric continuous renal replacement therapy device [22][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the company, emphasizing the importance of clinical evidence in driving product acceptance and utilization [38][63] - The company is committed to investing in strategic initiatives while maintaining cost vigilance, with a focus on expanding its clinical education team and product pipeline [45][47] Other Important Information - The company ended Q3 2022 with $12.1 million in cash and cash equivalents, and after a public offering, the pro forma cash balance was approximately $22 million [46] - The company is on track to submit an IDE for the pediatric device by early 2024, indicating ongoing product development efforts [34] Q&A Session Summary Question: Can you discuss the placements and consoles? - Growth in console placements is driven by opening new accounts and expanding utilization in existing accounts, with customers upgrading to the smart flow system [55] Question: Can you talk about FTEs and new hires? - The company has fully staffed territories except for one account manager position, with all clinical education specialists in place [57] Question: Update on the HF trial and enrollment? - Currently, five sites are enrolling patients, with adjustments being made to the protocol to ensure proper patient enrollment [58] Question: Utilization of Aquadex in heart failure and cabbage patients? - Most utilization occurs post-procedure, with some accounts starting to use Aquadex pre-transplant [59] Question: Why is acceptance of ultrafiltration products taking time? - The main reason has been the lack of direct clinical evidence supporting the reduction in readmissions, but new data is expected to drive increased sales [62][63]